Effects of Levetiracetam on Tardive Dyskinesia: A Randomized, Double-Blind, Placebo-Controlled Study
J Clin Psychiatry 2008;69(4):546-554
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Objective: The goal of this study was to evaluate the efficacy
and safety of levetiracetam versus placebo for tardive dyskinesia (TD).
Method: This double-blind, placebo-controlled, randomized
study was conducted at the Connecticut Mental Health Center between September
2004 and April 2006. Antipsychotic-treated patients meeting Glazer-Morgenstern
criteria for TD were assigned at random to receive levetiracetam 500 mg/day to
3000 mg/day or placebo for 12 weeks. After completion of 12 weeks, patients
were permitted to receive open-label levetiracetam for a further 12 weeks. The
principal efficacy outcome measure was improvement in the Abnormal Involuntary
Movement Scale (AIMS) total score. Safety was assessed with an adverse event
scale, psychiatric symptom rating scales, weight, and hematologic tests.
Results: A total of 50 patients were randomly assigned to
treatment. AIMS total scores were moderate in severity at baseline. Mixed
regression models revealed that AIMS total scores declined 43.5% from baseline
in the levetiracetam group compared to 18.7% for placebo (p = .022). Patients
continuing levetiracetam in the open-label phase continued to improve, and
patients crossed over to open-label levetiracetam improved to a similar degree
as those initially assigned. Levetiracetam was well tolerated.
Conclusion: Levetiracetam appeared effective for TD in this
study. The mechanisms of its therapeutic effect are unclear but may involve
reducing neuronal hypersynchrony in basal ganglia. Future studies should
attempt to replicate the current results.
Trial Registration: clinicaltrials.gov Identifier: NCT00291213